A Multicenter, Randomized, Double-Blind, Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of BDB-001 Injection in Patients With ANCA-Associated Vasculitis
Status: Recruiting
Location: See all (50) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The primary aim is to study the efficacy of treatment with BDB-001 Injection to induce remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with cyclophosphamide followed by azathioprine, or in combination with rituximab
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 18 years old≤Age≤75 years old, male or female;
• Diagnosis of granulomatosis with polyangiitis(GPA) or microscopic polyangiitis(MPA)；
• Newly diagnosed or relapsed GPA or MPA that requires treatment with a full starting dose of prednisone plus cyclophosphamide/azathioprine or rituximab；
• Positive test for anti-proteinase 3(PR3) or anti-myeloperoxidase (MPO)；
• Estimated glomerular filtration rate ≥15 mL/minute/1.73 m\^2；
• At least 1 major item, or at least 3 non-major items, or at least the 2 renal items on BVAS；
Locations
Other Locations
China
Beijing Tsinghua Changgung Hospital
NOT_YET_RECRUITING
Beijing
Peking Union Medical College Hospital
NOT_YET_RECRUITING
Beijing
Peking University First Hospital
NOT_YET_RECRUITING
Beijing
Peking University International Hospital
NOT_YET_RECRUITING
Beijing
Peking University People's Hospital
NOT_YET_RECRUITING
Beijing
Peking University Third Hospital
NOT_YET_RECRUITING
Beijing
The Second Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
General Hospital of Hunan University of Medicine
NOT_YET_RECRUITING
Changde
Hunan Provincial People's Hospital
RECRUITING
Changsha
Xiangya Hospital Central South University (Nephrology Department)
NOT_YET_RECRUITING
Changsha
Xiangya Hospital Central South University(Rheumatism Immunity Branch)
NOT_YET_RECRUITING
Changsha
Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
The Second Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
Guizhou Provincial People's Hospital
NOT_YET_RECRUITING
Guiyang
The First Affiliated Hospital, College of Medicine, Zhejiang University
NOT_YET_RECRUITING
Hangzhou
The Second Affiliated Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Zhejiang Provincial People's Hospital
NOT_YET_RECRUITING
Hangzhou
The Second Affiliated Hospital of Harbin
NOT_YET_RECRUITING
Harbin
Affiliated Hospital of Inner Mongolia Medical University
NOT_YET_RECRUITING
Hohhot
General Hospital of Hunan University of Medicine
NOT_YET_RECRUITING
Huaihua
Shandong Provincial Hospital
NOT_YET_RECRUITING
Jinan
The First Hospital of Lanzhou University
NOT_YET_RECRUITING
Lanzhou
Liuzhou People's Hospital
NOT_YET_RECRUITING
Liuchow
The First Affiliated Hospital of Henan University of science and Technology
NOT_YET_RECRUITING
Luoyang
Jiangxi Provincial People's Hospital
NOT_YET_RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Nanjing Gulou Hospital
NOT_YET_RECRUITING
Nanjing
Nanjing University School of Medicine Affiliated Gulou Hospital
NOT_YET_RECRUITING
Nanjing
Guangxi Academy of Medical Sciences,The People's Hospital of Guangxi Zhuang Autonomous Region
NOT_YET_RECRUITING
Nanning
The First Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITING
Nanning
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Zhongshan hospital,Fudan University
NOT_YET_RECRUITING
Shanghai
Shengjing Hospital of China Medical University
NOT_YET_RECRUITING
Shengyang
Guangdong Provincial People's Hospital
NOT_YET_RECRUITING
Shenzhen
Peking university Shenzhen Hospital
NOT_YET_RECRUITING
Shenzhen
The Second Hospital of Hebei Medical University City:Shijiazhuang
NOT_YET_RECRUITING
Shijiazhuang
Shanxi Bethune Hospital
NOT_YET_RECRUITING
Taiyuan
The Second Hospital of Shanxi Medical University
NOT_YET_RECRUITING
Taiyuan
The First Affiliated Hospital of Xinjiang Medical University
NOT_YET_RECRUITING
Ürümqi
Weifang People's Hospital
NOT_YET_RECRUITING
Weifang
Tongji Hospital,Tongji Medical college of Hust
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiao Tong University
NOT_YET_RECRUITING
Xi’an
Xijing Hospital
NOT_YET_RECRUITING
Xi’an
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
Affiliated Hospital of Yanbian University (Yanbian Hospital)
NOT_YET_RECRUITING
Yanbian
Yichang Central People's Hospital
NOT_YET_RECRUITING
Yichang
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Zhuzhou Central Hospital
NOT_YET_RECRUITING
Zhuzhou
Contact Information
Primary
Aiping Sun
sunaiping@staidson.com
+86 010-67519614
Time Frame
Start Date: 2025-11-10
Estimated Completion Date: 2028-02-29
Participants
Target number of participants: 300
Treatments
Experimental: BDB-001 injection group
BDB-001 injection plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.
Active_comparator: Prednisone group
BDB-001 injection-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.
Related Therapeutic Areas
Sponsors
Leads: Staidson (Beijing) Biopharmaceuticals Co., Ltd